Manufacturing Specialist

About the role

Amgen has built a next-generation biologics facility in Singapore and is looking for an experienced Manufacturing Specialist. Working with minimal direction or supervision, the specialist acts as the primary manufacturing contact for new product and technology introduction, manages manufacturing-related projects, drives productivity and continuous improvement, manages site project prioritization and helps manage department financial budgets.

Key responsibilities

• Lead manufacturing for site and facility fit assessments for new products and represent Amgen in Digital Tech Transfer initiatives
• Drive improvements in NPI workflow and act as NPI lead, ensuring cross-functional readiness (manufacturing, supply chain, engineering, automation, EHS, validation)
• Develop and manage the NPI schedule and budget, and prepare manufacturing documents such as SOPs, batch records and BOMs
• Serve as SME during regulatory inspections for change controls, deviations, investigations and CAPA
• Lead site projects for new equipment and technology, including change control ownership, and develop business cases and feasibility assessments
• Take part in wet tests, and provide input on URS, commissioning and qualification protocols
• Own manufacturing productivity targets, support continuous improvement and EIO/OIA award submissions, and eliminate waste through value stream mapping
• Drive digital transformation with digital tools, dashboards and workflow solutions, and support automation and digitalization advances
• Manage the manufacturing budget, support finance requests and handle purchase requisitions in SAP

Required profile

• Doctorate, or Master's in Engineering/Science with 2 years' experience in a pharma company or GMP environment, or Bachelor's with 4 years' experience
• Or Diploma in Engineering/Science with 8 years' experience in a pharma company or GMP environment
• Team leadership, strong communication and analytical skills, attention to detail and project management
• Ability to coach, train and develop manufacturing associates

Required skills

• Knowledge of facility and manufacturing processes
• MS Project, MS Excel, SAP, PI-Vision, Smartsheet, Spotfire

The selection is subject to meeting the medical requirements of the role, and the company bears the cost of any required medical checks.